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Kinase Inhibitor

Ibrutinib for Chronic Lymphocytic Leukemia (MERIT Trial)

Phase 2
Waitlist Available
Led By Sikander Ailawadhi, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of B-cell chronic lymphocytic leukemia (B-CLL), confirmed by flow cytometry and as per the criteria outlined by the IWCLL/Hallek December 2008
Patients must have a sustained clinical response (PR, nodular PR [nPR], complete clinical response [CCR], CR with incomplete marrow recovery [CRi], CR) with documented residual disease (>= 1 CLL cell per 10,000 leukocytes or >= 0.01% MRD) either in the blood, bone marrow or a lymph node >= 3.5 cm by any available techniques
Must not have
Men or women of childbearing potential who are unwilling to employ adequate contraception
Patients who are already MRD- (both in the blood and the bone marrow) after frontline therapy and have lymph nodes < 3.5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the 48 week mrd evaluation until the time of initiation of subsequent treatment for progressive cll, assessed up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial studies the side effects and effectiveness of ibrutinib in treating patients with CLL who responded to initial treatment, but have residual disease. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Who is the study for?
This trial is for patients with chronic lymphocytic leukemia (CLL) who have had some response to initial cancer treatment but still have residual disease. They must understand the study and consent, not be nursing or pregnant, and can't join if they've had certain other cancers, are MRD-negative after frontline therapy, need strong CYP3A modulators, or have serious liver impairment.
What is being tested?
The trial tests Ibrutinib's effectiveness in treating minimal residual disease in CLL patients post front-line therapy. It aims to see if Ibrutinib can halt cancer growth by inhibiting enzymes needed for cell proliferation. Participants will also provide samples for laboratory biomarker analysis.
What are the potential side effects?
Ibrutinib may cause side effects such as diarrhea, bleeding problems, high blood pressure, fatigue, muscle and bone pain. Some people might experience infections or heart rhythm issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leukemia is confirmed as B-CLL by specific blood tests.
Select...
I have a type of leukemia and still have some cancer cells despite treatment.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am of childbearing age and do not plan to use birth control.
Select...
I am MRD- after initial treatment and my lymph nodes are smaller than 3.5 cm.
Select...
I have severe liver problems.
Select...
I am currently taking warfarin or similar blood thinners.
Select...
I am currently breastfeeding.
Select...
My condition has worsened or returned after treatment.
Select...
I have active infectious hepatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the 48 week mrd evaluation until the time of initiation of subsequent treatment for progressive cll, assessed up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the 48 week mrd evaluation until the time of initiation of subsequent treatment for progressive cll, assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of confirmed MRD-negative response
Secondary study objectives
Duration of MRD-negative response
Improvement in Clinical Response
Incidence of adverse events
+3 more

Side effects data

From 2022 Phase 3 trial • 201 Patients • NCT03053440
37%
Diarrhoea
32%
Upper respiratory tract infection
29%
Muscle spasms
28%
Contusion
24%
Arthralgia
24%
Hypertension
22%
Oedema peripheral
22%
Anaemia
21%
Epistaxis
20%
Cough
19%
Rash
19%
Fatigue
18%
Back pain
18%
Atrial fibrillation
17%
Urinary tract infection
16%
Neutropenia
16%
Thrombocytopenia
15%
Nausea
15%
Headache
15%
Vomiting
14%
Pneumonia
14%
Dizziness
13%
Haematuria
12%
Peripheral swelling
12%
Pyrexia
12%
Constipation
11%
Localised infection
10%
Pain in extremity
10%
Onychoclasis
10%
Fall
10%
Oropharyngeal pain
10%
Lower respiratory tract infection
10%
Sinusitis
10%
Palpitations
9%
Insomnia
9%
Nasopharyngitis
9%
Hyperuricaemia
9%
Dyspnoea
9%
Haematoma
8%
Skin laceration
8%
Paraesthesia
7%
Dyspepsia
7%
Dry skin
7%
Cellulitis
7%
Conjunctivitis
7%
Skin infection
7%
Iron deficiency
7%
Anxiety
7%
Rhinitis
6%
Cataract
6%
Conjunctival haemorrhage
6%
Pruritus
6%
Hypokalaemia
6%
Syncope
6%
Vision blurred
6%
Abdominal pain
6%
Abdominal pain upper
6%
Nail infection
6%
Neck pain
6%
Purpura
6%
Asthenia
5%
Chest pain
5%
Abdominal discomfort
5%
Gingival bleeding
5%
Mouth ulceration
5%
Stomatitis
5%
Onychomycosis
5%
Rhinorrhoea
5%
Actinic keratosis
5%
Dermatitis
5%
Petechiae
5%
Influenza like illness
5%
COVID-19
5%
Gastroenteritis
5%
Tooth infection
5%
Limb injury
5%
Squamous cell carcinoma of skin
5%
Peripheral sensory neuropathy
5%
Rosacea
5%
Increased tendency to bruise
5%
Gout
5%
Basal cell carcinoma
5%
Folliculitis
5%
Oral herpes
5%
Gastrooesophageal reflux disease
4%
Retinal haemorrhage
4%
Dry mouth
4%
Angina pectoris
4%
Vertigo
4%
Haemorrhoids
4%
Ecchymosis
4%
Sepsis
4%
Chills
4%
Bronchitis
4%
Furuncle
4%
Joint injury
4%
Blood alkaline phosphatase increased
4%
Neutrophil count decreased
4%
Decreased appetite
4%
Joint swelling
4%
Depression
4%
Productive cough
4%
Skin ulcer
4%
Atrial flutter
4%
Hyperglycaemia
4%
Herpes zoster
3%
Bladder transitional cell carcinoma
3%
Tinnitus
3%
Rotator cuff syndrome
3%
Sinus bradycardia
3%
Inguinal hernia
3%
Dysphagia
3%
Dry eye
3%
Dysuria
3%
Abdominal distension
3%
Pollakiuria
3%
Hypoalbuminaemia
3%
Osteoporosis
3%
Erythema
3%
Acute myocardial infarction
3%
Malaise
3%
Cystitis
3%
Alanine aminotransferase increased
3%
Gamma-glutamyltransferase increased
3%
Musculoskeletal chest pain
3%
Seborrhoeic keratosis
3%
Neuralgia
3%
Benign prostatic hyperplasia
3%
Dyspnoea exertional
3%
Nasal congestion
3%
Pneumonitis
3%
Psoriasis
3%
Skin fissures
3%
Skin lesion
3%
Laryngitis
3%
Respiratory tract infection
3%
Bradycardia
3%
Acute kidney injury
3%
Wound infection
3%
Myalgia
3%
Skin toxicity
3%
Ear infection
3%
Paronychia
3%
Osteoarthritis
3%
Pericarditis
3%
Sciatica
3%
Ocular hyperaemia
3%
Nail disorder
2%
Pleural effusion
2%
Rectal haemorrhage
2%
Cholecystitis
2%
COVID-19 pneumonia
2%
Drug withdrawal syndrome
2%
Seasonal allergy
2%
Vitamin D deficiency
2%
Rash maculo-papular
2%
Hypotension
2%
Death
2%
Loss of consciousness
1%
Post procedural haemorrhage
1%
Lumbar vertebral fracture
1%
Laryngeal oedema
1%
Stress fracture
1%
Haemolytic anaemia
1%
Haemorrhagic disorder
1%
Viral infection
1%
Wound infection staphylococcal
1%
Cardiac failure acute
1%
Wheezing
1%
Colitis
1%
Oral blood blister
1%
Upper gastrointestinal haemorrhage
1%
Drug-induced liver injury
1%
Bacterial sepsis
1%
Brain abscess
1%
Device related infection
1%
Gastrointestinal infection
1%
Neurocryptococcosis
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Femoral neck fracture
1%
Femur fracture
1%
Subdural haematoma
1%
Lethargy
1%
Subarachnoid haemorrhage
1%
Chronic kidney disease
1%
Urinary bladder haemorrhage
1%
Prostatitis
1%
Acute pulmonary oedema
1%
Hyponatraemia
1%
Muscular weakness
1%
Rash erythematous
1%
Hyperviscosity syndrome
1%
Melaena
1%
Clostridium difficile infection
1%
Post procedural sepsis
1%
Pyelonephritis
1%
Cerebrovascular accident
1%
Respiratory disorder
1%
Lymphadenopathy
1%
Streptococcal sepsis
1%
Amyloidosis
1%
Influenza
1%
Pneumonia viral
1%
Coronary artery disease
1%
Pericardial haemorrhage
1%
Urosepsis
1%
Spinal stenosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Ibrutinib
Arm B: Zanubrutinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (ibrutinib)Experimental Treatment2 Interventions
Patients receive ibrutinib PO QD on days 1-28. Treatment repeats every 4 weeks\* for up to 36 courses in the absence of disease progression or unacceptable toxicity. Note: \*The last course may last up to 56 days to accommodate the study drug discontinuation visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 4
~2060

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,447 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,025 Total Patients Enrolled
Sikander Ailawadhi, M.D.Principal InvestigatorMayo Clinic
5 Previous Clinical Trials
3,359 Total Patients Enrolled

Media Library

Ibrutinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02649387 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (ibrutinib)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Ibrutinib Highlights & Side Effects. Trial Name: NCT02649387 — Phase 2
Ibrutinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02649387 — Phase 2
~4 spots leftby Nov 2025
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